Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study

NCT06716554 | Recruiting

• 1 other identifier: SHT-1076-2024-1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari for the treatment of Menopausal symptoms in Women. Participants will be randomized to either one of the three treatment arms.Participants will then be asked to either take one capsule containing Shatavari or Shatavari + Ashwagandha or Placebo orally once daily in the morning after breakfast with a glass of water for 8 weeks. All the subjects will be asked to continue their routine diet and physical activities during the whole study period. The primary objective is to compare the efficacy of shatavari for treatment of menopausal symptoms in women. The secondary objective is to compare the safety of shatavari for treatment of menopausal symptoms in women.

Conditions

Menopause; Hot Flashes; Mood

Outcome Measures

Primary Outcomes (1)

• Menopause Rating Scale (MRS)

  The scale consisted of 11 items, ranging from no symptoms to very severe symptoms. The total score of the MRS ranges from 0 (asymptomatic) to 44 (highest degree of complaints). The minimal/maximal scores vary between the three dimensions, depending on the number of complaints allocated to the respective dimension of symptoms.

  MRS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).

Secondary Outcomes (4)

• Perceived Stress Scale (PSS)

  PSS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).

• Menopause-Specific Quality of Life Questionnaire (MENQOL)

  MENQOL assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).

• Profile of Mood States (POMS, abbreviated version)

  POMS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), Visit 3 End of study visit, (Week 8).

• Serum Hormones

  Blood samples for Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) will be collected at Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1) and Visit 3- (Week 8)

Study Arms (3)

Shatavari

EXPERIMENTAL

One capsule of Shatavari 300 mg (contains Shatavari extract) once a day, orally with water.

Dietary Supplement: Shatavari extract

Shatavari + Ashwagandha

EXPERIMENTAL

One capsule of Shatavari (300mg) + Ashwagandha (250mg) (contains Shatavari + Ashwagandha root extract) once a day, orally with water.

Dietary Supplement: Shatavari + Ashwagandha extract

Placebo

PLACEBO COMPARATOR

One capsule of Placebo 300 mg (contains starch extract) once a day, orally with water.

Dietary Supplement: Placebo

Interventions

Shatavari extract DIETARY_SUPPLEMENT

Shatavari is scientifically known as Asparagus racemosus. One capsule containing Shatavari 300mg should be taken once daily.

Shatavari

Shatavari + Ashwagandha extract DIETARY_SUPPLEMENT

Shatavari is scientifically known as Asparagus racemosus along with Ashwagandha root extract scientifically known as Withania somnifera. One capsule containing Shatavari 300mg + Ashwagandha root extract 250mg should be taken once daily.

Shatavari + Ashwagandha

Placebo DIETARY_SUPPLEMENT

Placebo (starch)

Placebo

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Menopausal women aged 45 to 65 years with intact uterus and ovaries.
• Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days
• Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
• Body mass index 18-35 kg/m2
• Subject who has given written informed consent to participate in the study and understand the nature of the study
• Able to read and write in English or any other vernacular language
• No plan to commence new treatments over the study period.
• Must have the ability and willingness to sign an informed consent and to comply with all study procedures.

You may not qualify if:

• Participants taking any form of herbal extract in the last 3 months before study entry.
• Participants who are on hormone replacement therapy (HRT) for more than 3 months.
• Participants with Present active medical, surgical, and gynaecological problems.
• Participants with a history of alcohol, tobacco dependence, or any substance abuse
• Participants who had undergone bilateral ovariectomy
• Participants with history of breast or cervical carcinoma
• Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate.
• Participants with Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult
• Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
• Participants with evidence of uncooperative attitude, including poor compliance.
• Participants with inability to attend follow-up visit
• Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.
• Patients with known hypersensitivity to Ashwagandha.
• Patients who had participated in other clinical trials during the previous 3 months.
• Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol

Sponsors & Collaborators

• SF Research Institute, Inc.: lead
• Ixoreal Biomed Inc.: collaborator

Study Sites (1)

SF Research Institute, Inc.

San Francisco, California, 94127, United States

RECRUITING

Related Publications (1)

• Ademola J, Ajgaonkar A, Debnath T, Debnath K, Langade J. Efficacy and safety of Shatavari root extract (Asparagus racemosus) for menopausal symptoms: a randomized, double-blind, three-arm, placebo-controlled study. Front Reprod Health. 2025 Nov 27;7:1654503. doi: 10.3389/frph.2025.1654503. eCollection 2025.

  PMID: 41394012 DERIVED

MeSH Terms

Conditions

Hot Flashes

Interventions

Ashwagandha

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Khaleeq Rehman

CONTACT

+1 (415) 690-9641; khaleeqr.sfinstitute@gmail.com

John Ademola

CONTACT

+1 (415) 845-4638; jademola@sfinstitute.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: October 26, 2024
• Primary Completion: December 26, 2024
• Study Completion: January 20, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

US (1)